Isotretinoin 10mg Capsules
Out of date information, search anotherThe name of your medicine is Isotretinoin 10 mg or 20 mg ' s (also referred to as Isotretinoin Capsules or Isotretinoin
Capsules (also re throughoutthis lei
1. What Isotretinoin Capsules is and what it is used for
2. Before you take Isotretinoin
3. How to take Isotretinoin Capsules
4. Possible side effects
5 Howto store Isotretinoin Capsules 6. Further Information
1. WHAT ISOTRETINOIN CAPSULES IS AND WHAT IT IS USED FOR
Isotretinoin Capsules contain the active Ingredient isotretinoin.This is a vitamin A derivative, belonging to the retinoid class of medicines. Isotretinoin is used to treat severe forms of acne (such as nodular or conglobate acne, or acne at risk of permanent scarring) which has not got better after other treatments, including oral antibiotics.
st be supervised by a dermatologist (a reatment of skin problems). Isotretinoin
doctor specialised in the treatment of skin problems). I capsules are not used to treat acne occurring before puberty, or In children youngerthan 12 years of age.
2. BEFORE YOU TAKE ISOTRETINOIN
Do not take Isotretinoin Capsules:
. If you are pregnant orthlnk you may be pregnant . If you are breastfeeding . If you have liver disease
. if you have very high levels of lipids (cholesterol, triglycerides) in your blood
. If you have very high levels of vitamin A in your body (hypervitaminosisA)
. if you are hypersensitive (allergic) to isotretinoin or any of the other ingredients of Isotretinoin Capsules.
. if you aretaking tetracyclines (a type of antibiotic medicine)
Isotretinoin capsules may Increase the levels of fats such as triglycerides or cholesterol In your blood. Ybu r doctor will do some blood teste in order to monitor these levels before, during and at the end of your treatment with isotretinoin. Pleasetell your doctor if you already have high levels of these substances in your blood orif you have diabetes, are overweight, or are an alcoholic, as you may need to get the blood tests more frequently.
Isotretinoin Capsules may increase your liver enzyme levels. Ybur doctor will do some blood teste before, during and at the end of yourtreatment with Isotretinoin to check your liver values. In cases where liver enzyme values remain high your doctor may reduce yourdose or stop your Isotretinoin therapy.
Isotretinoin Capsules may Increase your Wood sugar levels and In rare cases diabetes mellltijs has been diagnosed. Yourdoctor may monitor your blood sugar levels during yourtreatment, particularly If you have diabetes, are overweight, or are an alcoholic.
Use a skin moisturising ointment or cream and a lip balm during treatment as you may experience skin or lips dryness or both during isotretinoin therapy.
Rare cases of depression, worsening depression, anxiety, mood changes, psychotic symptoms and very rarely suicidal thoughts, suicide attempts and suicide have been reported. If you have any kind of mental problems, or, If you think you have signs of depression while taking Isotretinoin, such as feeling very sad for no reason, crying spells, difficulty concentrating or you become withdrawn from your friends or family, please Inform your doctor. Your doctor may refer you for appropriate treatment If necessary. Discontinuation of your isotretinoin therapy may not be enough to relieve symptoms and you may require further psychiatric or psychological help.
If you experience an allergic reaction (skin redness, itching) ora serious anaphylactic reaction, please stop your therapy immediately and contact your doctor as soon as possible. Isotretinoin Capsules have been very rarely associated with a condition called benign Intercranlal hypertension. If you experience a persistent headache, nausea, vomiting and Wurred vision, please stop your therapy Immediately and contact your doctor as soon as possible.
Capsules have on very rare with inflammatory bowel disease. If you . severe hemorrhagic diarrhoea (e.g. Wood in your stool), stop therapy immediately and contact your doctor as soon as
is therapy may affect your night vision. You may develop dry eyes or sight problems during Isotretinoin therapy which normally returns to normal once treatment Is stopped. Always be cautious when driving or operating machinery at night because these sight changes can happen quite suddenly. If you wear contact lenses and experience dry eyes you may need to wear glasses tor toe duration of isotretinoin treatment. If you experience any problems with your sight, please inform your doctor immediately, as your Isotretinoin Capsules may need to be stopped and yoursight monitored.
Your skin may become more sensitive to sunlight during Isotretinoin therapy. Avoid too much sun and do not use a sunlamp or sun-bed. Before going out In toe sun apply a sun-protection product with a high protection factor of at least SPF15. Isotretinoin may make your sldn more fragile. Cosmetic procedures such as dermabrasion or laser treatments (removal of homy skin or scars) and wax depilation should be avoided during and for at least 6 months after treatment as this could cause ras’iMtf'Aa have been observed during isotretinoin treatment, care should be taken to reduce intensive physical activity during isotretinoin therapy.
Do not donate blood either during or for one month after Isotretinoin treatment If someone who Is pregnant receives your donated blood, her baby may be bom wtto serious birth defects. Tildng other medicines:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal products, even those not prescribed. Do not taka vitamin A supplements or ........ "is (a type of antibiotic) or use any skin treatments for
Important
Isotretinoin Is teratogenic. That means It Is likely to damage baby. There Is also an Increased risk ol
You must not take Isotretinoin Capsules if you are pregnant or may become pregnant at any time during treatment and for one month after treatment has stopped.
Ybu have severe acne (such as nodular or conglobate acne or acne at risk of permanent scarring) which has not got better after other anti-acne treatments, including oral
. Your doctor has explained the teratogenic risk of isotretinoin, and you understand why you must not get pregnant and how
to prevent pregnancy.
. You have discussed usl
d using effective contraception with your doctor Ybur doctor will give you Information on pregnancy prevention Including a brochure on contraception explaining the different methods. He or she may referyou to a specialist for contraceptive advice.
. Ybu agree to use at least one and preferably two effective methods of contraception for one month before you start isotretinoin treatment, during treatment and for one month after treatment ends. Before you start treatment yourdoctor will askyou to take a pregnancy test which must be negative. . Ybu use contraception even if you do not have periods or are not currently sexually active, unless your doctor decides this is not necessary.
. Ybu understand and accept the need for monthly follow up visits and maybe further pregnancy tests as decided by your doctor. Ybu may then have a pregnancy test 5 wBeks after stopping your isotretinoin therapy. Ybu must not become pregnant at any time during treatment or for one month after treatment ends.
. Your doctor may ask you (or your guardian) to sign an acknowledgment form where you confirm that you have been Informed about the risks of Isotretinoin treatment and that you acceptthe necessary precautionary measures.
If you become pregnant while on Isotretinoin therapy or during the month after treatment has stopped, Immediately stop taking themedicineandcontactyourdoctor.Heorshe may rater you to aspecialisttorevaluation and advice.
s subject is available from your 1 received this meterial pleese contact
Prescriptions are limited to 30 days treatment for women of childbearing potential. Continuation of treatment requires a new prescription, and each prescription Is only valid torseven days.
Treatment with isotretinoin does not appear to damage sperm. Isotretinoin and its metabolites are present at very low levels in your semen. These levels are considered too low to harm the unborn baby of your female partner.
You must remember not to share your medication with anyone, particularly not females.
Driving and using machines
Your night vision may get worse during your treatment This can happen suddenly. In rare cases this has continued after the treatment has stopped. Drowsiness and dizziness have been reported very rarely. If this happens to you, you should not drive or operate machinery.
me the Ingredients of
Isotretinoin capsules contain soya oil. If you are allergic to peanut or soya, do not use this medicinal product. This medicinal product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
3. HOWTO TAKE ISOTRETINOIN CAPSULES
Always take Isotretinoin Capsules exactly as your doctor has Instructed you. You should check with yourdoctor or pharmacist If you are unsure.
The usual starting dose is 0.5 mg per kilogram bodyweight per day (0.5 mg/Kg/day). After a few weeks your doctor may adjust your dose. This will depend on how you are getting on with your medicine. For most of the patients dose will be between 0.5 and 1.0 mg/Kg/day. If you have toe impression that the effect of isotretinoin is too strong or too weak, talk to your doctor or
be started at a lower dose such as 10 mg/day and to to highest tolerated dose
If you do not tolerate toe recommended dose, your doctor may continue yourtreatment at a lower dose with toe consequence of a longer therapy duration and a higher risk of relapse.
The capsules should be fatten with food once or twice daily. Swallowthe capsules whole, do not chew orsucktoem. Occasionally your acno may get worse during the first weeks ot treatment. It should Improve with continued treatment.
A course of treatment usually lasts for 16 to 24 weeks. Your acne may continue to improve for up to 8 weeks after toe treatment finishes. Therefore, a further course of treatment should not be started until at least this period has elapsed. Most patients only need a single course of treatment.
Please return any unusBd capsules to your pharmacist at toe end of treatment Only keep It If you dcctortells you to. Remember this medicine Is for you. Only a doctor can prescribe It for you. Never give It to others. It may harm them even If their symptoms look similar to yours.
It you late more Isotretinoin Capsules than you should:
If you take too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital immediately.
If you forgetto take Isotretinoin Capsules:
If you miss a dose, take It as soon as possible. However if it is nearly time for your next dose, skip toe missed dose and carry on as before. Do not take a double dose to make up for a forgotten
PACKAGE LEAFLET INFORMATION FORTNE USER
ISOTRETINOIN 10 MG CAPSULES ISOTRETINOIN 20 MG CAPSULES
Keepttiisleaflet.Youmay need to read it again.
If you have any further questions, ask your doctor or your pharmacist
This medicine has been prescribed for you. Do not pass it or to others, it may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed In this leaflet please tell your doctor or
acne during Isotretinoin therapy.
is with food and drink
Isotretinoin Capsules should betaken with food.
Pregnancy and Breast-feeding Female patients:
. IsotrBtinoinCapsu Ibs must not be taken during pregnancy.
. You must not take Isotretinoin Capsules If you are breastfeeding, because Isotretinoin Is likely to pass Into tho mllkand may harm the baby:
If you stop taking Isotretinoin Capsules
If you stop taking tho medicine your symptoms may return. You should check with yourdoctor or pharmacist if you are notsure.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Isotretinoin capsules can cause side effects, although not everybody gets them, These effects often wear off as yourtreatment continues or after treatment has stopped. Your doctor can helpyou to deal with them.
On rare occasions, some patients taking isotretinoin or soon after stopping isotretinoin have become depressed or developed other serious mental problems. Symptoms include sad or empty mood, mood changes, anxiety, crying spells, irritability, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down or trouble concentrating. Rarely, patients who already have depression may feel worse.
Very rarely, some patients taking Isotretinoin have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people have tried to end toelr own lives (suicide attempt), and some people have ended their lives (suicide). There have been reports that some of these people did not appear depressed.
Rarely, there have been reports of patients on isotretinoin becoming violent or aggressive.
Very rarely unusual behavior and signs of psychosis: a loss of contact with reality, such as hearing voices or seeing things that are notthere have been reported.
As menial problems can be caused by many different factors, it is important to tell your doctor Ifyouhaveeverhadany mental illness including depression, suicidal behaviour or psychosis (psychosis means a loss of contact with reality, such as hearing voices or seeing things that are not there). Also toll your doctor if you take medicines for any of these conditions.
If you think you are developing any of these mental conditions or the symptoms of depression you should contact your doctor right away. You may be advised to stop taking Isotretinoin Capsules. However, stopping yourtreatment may not be sufficient to relieve your symptoms and you may need further help which your doctor can arrange.
Serious skin rashes (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which are potentially lifB-toraatening and require immediate medical attention. These appear initially as circular patches often with central blisters usually on arms and hands or legs and feet, more severe rashes may include blistering of the chest and back. Additional symptoms such as infection of toe eye (conjunctivitis) or ulcers of toe mouth, throat or nose may occur. Severe forms of rash may progress to widespread peeling of toe skin which can be life threatening. These serious skin rashes are often preceded by headache, fever, body aches (ftu-llke symptoms). These side effects have been reported wtto unknown frequency.
If you develop a rash or these skin symptoms, stop taking isctretinoi n and contact you r doctor i mmediately.
It is very common to experience dryness of the skin, especially of the lips and face. Ybu may get an inflamed skin (dermatitis), chapped and inflamed lips (cheilitis), a rash, some mild Itching and slight peeling. This dryness can be relieved by the regular use of a good moisturising cream from the start of treatment.
It Is very common foryour sldn to become more fragile and redder than usual, particularly on the face.
Very rarely, you may experience excess sweating, Itching or develop increased sensitivity to light.
Occasionally your acne may get worse during toe first weeks of treatment. Ybur skin can in very rare cases appear inflamed and swollen, with increased facial pigmentation. However, your acne and other symptoms should improve with continued treatment Ybu may very rarely experience local bacterial infections of the tissue around the base of toe nail, swellings discharging pus, changes In the nails, thickened scarring after surgical Interventions and Increased levels of body hair.
Allergic reactions
Rarely allergic reactions such as sldn rashes and Itohlness have been reported in patients receiving isotretinoin. Serious reactions (anaphylactic reactions) may be associated with a tightness in your chest and difficulty breathing. If you experience an allergic reaction stop taking Isotretinoin Capsules and contactyour doctor, jf you have a serious reaction, gat emergency medical help
If you have any allergic reaction, stop taking isotretinoin and contact your doctor.
It Is very common for patients to develop blood disorders, which affect different cells In toe blood. The cells Involved In clotting may be affected, which means you may bruise or bleed more easily. If toe red blood cells are affected you may develop anaemia. If the white cells in toe blood, which fight infection, are affected you may become more susceptible to infection. Your blood will be regularly monitored throughout your treatment. Very rarely your lymph glands may become swollen.
particularly when Isotretinoin I antibiotics (tetracyclines). If you experience a persistent headache wtto nausea, vomiting and blurred vision, this may mean that you have developed a benign Intracranial hyperteislon. Stop taking Isotretinoin Capsules as soon as possible and contact your doctor. Headache is a common side effect associated with isotretinoin treatment. Convulsions, dizziness and drowsiness have been reported very rarely.
(blepharitis) Is very common. It Is very common foryour eyes to feel dry and slightly Irritated. Ask your pharmacist to suggest some suitable eye drops to help. Very rarely, contact lens wearers may have to wear glasses for toe duration of treatment due to dryness oftoe eyes.
Very rarely, your night vision may be affected by this medicine making it hartierto see atnight
Isotretinoin can cause colour blindness and some patients are less able to distinguish colours.
Sensitivity to light may increase and you may find that you need to wear sunglasses to protect your eyes from too bright sunlight.
In very rare cases, patients have experienced other sight problems (vision disturbances], such as blurred vision, corneal opacities and cataracts (clouding oftoe surface oftoe eye). If your sight is affected at all by this medicinetell yourdoctoras soon as possible.
Nose and throat
It is common for the inside of your nose to become dry or bleed; throat and nose to get sore or inflamed and very rarely, you may experience dryness of toe throat which may cause hoarseness or sudden chest tightness with shortness of breath and wheezing (bronchospasm), particularly in patients with asthma.
If you experience severe abdominal pain with or without severs bloody diarrhoea, nausea and vomiting, stop taking isotretinoin as soon as possible and contact your doctor. There have been very rare reports of patients experiencing serious gastrointestinal disturbances, such as pancreatitis, gastrointestinal haemorrhage, colitis, Ileitis and Inflammatory bowel disease.
Liver problems
It Is very common for patients to experience Increase In toe level of liver enzymes. These are identified by the bloodtests that are token throughout your treatment Very rarely patients have developed more serious liver problems (hepatitis). If you experience yellowing of the skin or eyes with tiredness, stop taking your medication as soon as possible and contactyour doctor.
In very rare cases, patients may experience Inflammation of their kidneys. Symptoms Include feeling excessively tired, difficulty urinating as well as swollen and puffy eyelids. If this occurs while you are taking your medicine, stop the therapy and contact your doctor.
On very rare occasions patients have developed diabetes, symptoms include excessive thirst and a frequent need to urinate or your blood tests may show an increase in your blood sugar levels.
You may notice some changes to your hair (either a loss or, rarely an Increase) after taking this medicine for a while. This Is usually only temporary and persistent hair thinning Is rare. Your hair should return to normal after toe treatment ends.
Back pain, muscle pain and pain of toe joints have been very commonly reported during isotretinoin treatment (particularly in children and teenagers).
To avoid making any bone or muscle problems worse, care should be taken to reduce intensive physical activity during isotretinoin therapy.
In addition, on some very rare occasions, It has been reported that you may develop arthritis, muscle weakness, bone disorders (Including delayed growth, exostoses and changes to bone density), calcifications in soft tissues, occasional soreness of toe tendons and an abnormal level of muscle degradation products in yourblood if you exercise vigorously while taking your medication. Bones that have not finished toelr normal growth may stop growing prematurely.
VBry commonly changed levels of fats in toe blood (including HDL or triglycerides) have been reported.
Common reported side effects are higher levels of cholesterol In the blood, protein or blood In toe urine.
Very rare effects include generally feeling unwell, high levels of uric acid in the blood, bacterial infections and inflammation of the blood vessels (sometimes with bruising, rad patches).
If any of toe side effects gets serious or If you notice any side effects not listed In this leaflet, please tell you doctor or pharmacist.
5. HOW TO STORE ISOTRETINOIN CAPSULES
Keep out of the reach and sight of children.
Do rot use after toe expiry date (EXP) which Is stated on toe carton. The expiry date referatotoe last day oftoe month.
Do not store above 25°C.
Store in toe origi nal package. Keep toe contai ner in toe outer carton in orderto protectfrom light and moisture
Medicines should not be disposed of via wastewater or household water. Askyour pharmacist howto dispose of medicines no longer required. These measures will help to protect the environment
6. FURTHER INFORMATION What Isotretinoin Capsules contains
. Tbe active substance Is Isotretinoin . Tbe other Ingredients are soyabean oil hydrogenated, hydrogenated vegetable oil (Type II USNF), beeswaxwhlte, disodium edelate, butyl hydroxyanisole, soyabean oil refined and polysorbateUO.
. Tbe capsule shell contains gelatin, glycerol, titanium dioxide (E171), methyl parahydroxybenzoate and propyl parahydroxybenzoate. The colourant that has been used in the capsules is either ferric oxide red (E172) for toe 10 mg capsules orf D&C Red No 3, FD&C Blue No 1 and Brilliant Blue FCF (E133) for toe 20 mg capsules. The (Opacode S-1 -17823 Black) printing ink contains shellac glaze, ferric oxide black (E172) and propylene glycol.
What isotretinoin Capsules looks Hire and contents of the pack
Isotretinoin 10 mg Capsules are oval shaped, light pink coloured soft capsules and contain 10 mg of Isotretinoin as the active soft capsules and contain 20 mg of isotretinoin as toe active
Isotretinoin 10mg Capsules are available as blister strips in pack sizes of 30,50,56 and 60 capsules.
Isotretinoin 20mg Capsules are available as blister strips in pack sizes of 30,50,56,60 and 100 capsules.
Not all pack sizes may be available In the market
Marketing Authorization Holder Ranbaxy (UK) Limited,
Building 4, Chiswick Park 566 Chiswick High Road London, W45YE,
United Kingdom Manufacturer Ranbaxy Ireland Limited,
Spafield, Cork Road,
Cashel, Co-Tipperary,
Republic of Ireland.
This leaflet was last revised In May 2013.
RANBAXY